01 1HAS Healthcare Advanced Synthesis SA
02 1Kyongbo Pharmaceutical Co. , Ltd.
03 1Sanyo Fine Co., Ltd.
04 1Shiratori Pharmaceutical Co., Ltd.
01 1Dedicated to the production of palonosetron hydrochloride
02 2Palonosetron Hydrochloride
03 1Palonosetron hydrochloride
01 1Gabon
02 1Japan
03 1South Korea
04 1Switzerland
Registration Number : 220MF10072
Registrant's Address : Via Industria, 24 6710 Biasca Switzerland
Initial Date of Registration : 2008-03-14
Latest Date of Registration : 2009-06-16
Registration Number : 304MF10110
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2022-08-03
Latest Date of Registration : 2022-08-03
Palonosetron Hydrochloride For manufacturing purposes only
Registration Number : 302MF10012
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2020-01-24
Latest Date of Registration : 2020-01-24
Registration Number : 302MF10026
Registrant's Address : Osaka Prefecture, Osaka City, Nishi Ward, Awaza 1-12-18
Initial Date of Registration : 2020-02-06
Latest Date of Registration : 2020-02-06
A Palonosetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palonosetron, including repackagers and relabelers. The FDA regulates Palonosetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palonosetron API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Palonosetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Palonosetron supplier is an individual or a company that provides Palonosetron active pharmaceutical ingredient (API) or Palonosetron finished formulations upon request. The Palonosetron suppliers may include Palonosetron API manufacturers, exporters, distributors and traders.
click here to find a list of Palonosetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Palonosetron Drug Master File in Japan (Palonosetron JDMF) empowers Palonosetron API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Palonosetron JDMF during the approval evaluation for pharmaceutical products. At the time of Palonosetron JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Palonosetron suppliers with JDMF on PharmaCompass.
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